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A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors

A First-in-Human, Open-Label, Multi-Center Phase 1 Study of TST003 in Subjects With Locally Advanced or Metastatic Solid Tumors

NCT05731271•Suzhou Transcenta Therapeutics Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the safety of TST003 in patients with cancer. The main question\[s\] it aims to answer are: * What is the recommended dose patients can safely receive? * How long does this drug remain in the body after administration? * What are the side effects of this drug? * Does your cancer respond to TST003? * Participants on this study will get TST003 intravenously (through a needle into your vein), once every 3 weeks. * You may need to come to the study site 2-4 times to have tests to see if you are eligible to be in the study before you begin to receive the study drug. * After you start the study drug, you will need to return to the site several times after each dose so the physician can take vital signs, draw blood samples, and evaluate you for safety and wellbeing. * Participants will continue taking the drug as long as they are receiving clinical benefit. * At the end of your study participation, additional testing is required.

Detailed Description

Part 1 of the trial will consist cohorts, one dosed every 3 weeks at increasingly higher doses following the Bayesian Optimal Interval (BOIN) design. Part 1 is the dose finding portion of the trial. All locally advanced or metastatic solid tumors are accepted. 18 - 39 patients will be enrolled. Part 2 consists of 2 pharmacodynamic cohorts of approximately 26-36 patients respectively. For Part 2, participants must have locally advanced or metastatic colorectal cancer (CRC). The trial will last approximately 3 years, with assessments including but not limited to safety labs, ECGs, ECHO/MUGA, PKs and PDs and CT/MRI tumor assessments, and tumor biopsies based on emerging data found in Part 1.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 18 years of age at the time of informed consent.
•2. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
•3. Part 1: Subjects with histological or cytological diagnosed unresectable locally advanced or metastatic malignant solid tumors and who can provide archival tumor tissue. For Part 2: Subjects with histological or cytological diagnosed unresectable locally advanced or metastatic CRC and who can provide archival tumor tissue
•4. Subjects who have tumor progression during or after prior therapy and for whom no standard therapy exists that would confer clinical benefit.
•5. At least 1 measurable lesion per RECIST v1.1 ( Part 2 only).
•6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
•7. Life expectancy of 12 weeks or more.
•8. Calculated creatinine clearance ≥30 mL/min per the Cockcroft and Gault formula. 9.Adequate bone marrow function:
•* Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 ×103/L);
•* Platelets ≥ 100,000/mm3 (≥ 100 × 109/L);
+4 more criteria

Exclusion Criteria

•1. Untreated or symptomatic central nervous system (CNS) metastases. Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroid for at least 4 weeks following CNS -directed therapy are eligible for study entry.
•2. Prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, or targeted therapy or herbal medicine) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug.
•3. Radical radiation or local-regional therapies (transarterial chemoembolization or radiofrequency ablation) within 4 weeks prior to the first dose of study drug; palliative radiotherapy to a non-target lesion within 2 weeks prior to of study drug.
•4. Any unresolved Grade 2 or greater toxicity from previous anticancer therapy except alopecia.
•5. Any herbal medicine without anti-tumor intent within one week before the first dose of study drug.
•6. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases, including but not limited to pulmonary fibrosis, active pneumonitis.
•7. Severe cardiovascular disease, including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina, New York Heart Association (NYHA) class III or IV heart failure or uncontrolled arrhythmia within 6 months of the first dose.
•8. Has the average corrected QT interval by Fridericia's formula (QTcF) prolongation to \> 480 millisecond (ms) based on 12-lead ECG in triplicate, or with a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives).
•9. Uncontrolled hypertension (systolic pressure \>150mmHg or diastolic pressure \> 90mmHg).
•10. Severe intestinal disease, including but not limited to:
+15 more criteria

Locations (3)

OHSU

Portland, Oregon, United States

Mary Crowley

Dallas, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Key Dates

Start Date

February 8, 2023

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

December 17, 2025

Enrollment

111

ACTUAL participants

Conditions

Locally Advanced Solid TumorMetastatic TumorColorectal Adenocarcinoma

Interventions

TST003

DRUG

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NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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RECRUITINGPHASE1

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

NCT04511039

Advanced Malignant Solid NeoplasmClinical Stage III Gastroesophageal Junction Adenocarcinoma+27 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

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Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer

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